Senior Quality Operations Specialist

1 week ago


Sydney, New South Wales, Australia beBeeQuality Full time $95,000 - $115,000
Job Title: Senior Quality AssociateJob Description:    We are seeking a seasoned quality professional to support our operations. As the Senior Quality Assurance Associate, you will play a vital role in ensuring compliance with regulatory standards and internal procedures.    Your responsibilities will include providing day-to-day quality support across warehouse and operational functions. This involves ensuring adherence to client-specific requirements, regulatory standards, and internal procedures.    Key Responsibilities:    Quality Oversight & Compliance:    Ensure all warehouse and operational activities comply with internal procedures, client requirements, and applicable regulatory standards.    Issue Management & Resolution:    Investigate, document, and resolve Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Change Controls in a timely manner.    Customer & Stakeholder Engagement:    Provide clear and professional communication with customers regarding quality matters.    Process & System Integrity:    Oversee the integrity of SAS release, controlled destruction, and return to vendor sessions.    Training & Documentation:    Ensure training records and labeling processes are compliant and up-to-date.    Performance Monitoring:    Track and trend quality KPIs and metrics.Required Skills and Qualifications:    Solid knowledge of ISO 13485: Apply its principles in a healthcare, medical device, or pharmaceutical environment.    Solid understanding of TGA regulations: PIC/S Code of GMP (Good Manufacturing Practices) and GWP (Good Warehouse Practices).    Familiarity with ISO 9001: Integration with ISO 13485 for quality management systems.    Basic understanding of Supply Chain Management: Integrated Logistics.    FMCG, Medical Devices, Food Manufacturing, Pharmaceuticals industry experience: Highly advantageous.    Prior experience working in or with a logistics site: Also advantageous.Benefits:    This is an excellent opportunity to work in a dynamic environment and contribute to the success of our organization.Others:    Apply now to take your career to the next level.],

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